IP Library › Granted Patent US 12,491,210
Granted Patent B2
US 12,491,210 · App. 17/044,843 · Granted Dec 9, 2025

Methods of assessing and treating autism spectrum disorders using human umbilical cord tissue-derived mesenchymal stromal cells

Inventors: Joanne Kurtzberg (Durham, NC); Geraldine Dawson (Durham, NC); Jessica Sun (Durham, NC)
Assignee: Duke University
A61K35/28A61K9/0019A61P25/00
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Quick Facts
Patent No.
US 12,491,210
App. No.
17/044,843
Granted
Dec 9, 2025
Kind
B2
Abstract

The present disclosure provides methods of treating Autism Spectrum Disorder. More particularly, the present disclosure relates to methods of using cord blood tissue-derived mesenchymal stromal cells (hCT-MSCs) to treat Autism Spectrum Disorder. The methods involve treating a patient having or suspected of having an Autism Spectrum Disorder by administering a therapeutically effective amount of hCT-MSCs.

Claims (19)

1 . A method of treating a patient having or suspected of having an autism spectrum disorder, the method comprising administering a therapeutically effective amount of human allogeneic cord tissue-derived mesenchymal stromal cells (allogeneic hCT-MSCs) to the patient, wherein the therapeutically effective dose of allogeneic hCT-MSCs comprises a total of 6.0×10 6 cells/kg, and is administered in 2 to 3 doses within 6 months.

2 . The method of claim 1 , wherein the allogeneic hCT-MSCs are administered systemically.

3 . The method of claim 1 , wherein the allogeneic hCT-MSCs are administered intravenously.

4 . The method of claim 1 , wherein the patient is from 1 year old to 45 years old.

5 . The method of claim 4 , wherein the patient is from 2 years old to 11 years old.

6 . The method of claim 4 , wherein the patient is from 4 years old to 8 years old.

7 . The method of claim 1 , wherein each dose is administered from 1 month to 6 months apart.

8 . The method of claim 7 , wherein each dose is administered two months apart.

9 . The method of claim 1 , wherein three doses are administered and the dose comprises 2.0×10 6 cells/kg.

10 . The method of claim 1 , wherein two doses are administered and the dose comprises 3.0×10 6 cells/kg.

11 . The method of claim 1 , wherein the therapeutically effective dose of allogeneic hCT-MSCs is greater than 90% CD73+ and CD90+.

12 . The method of claim 1 , wherein the therapeutically effective dose of allogeneic hCT-MSCs is less than 10% CD45+, CD3+, or CD31+.

13 . A method of assessing the therapeutic effectiveness of treatment with human allogeneic cord tissue-derived mesenchymal stromal cells (allogeneic hCT-MSCs) on a patient suffering from an autism spectrum disorder comprising:

(a) performing one or more appropriate tests on the patient to establish behavioral and/or biomarker baseline score(s);

(b) administering an effective amount of allogeneic hCT-MSCs to the patient, wherein the effective amount of allogeneic hCT-MSCs comprises a total of 6.0×10 6 cells/kg, and is administered in 2 to 3 doses within 6 months;

(c) reevaluating the patient at one or more time points post-administration of allogeneic hCT-MSCs for the same one or more behavioral and/or biomarker tests set forth in (a); and

(d) comparing the results in (c) with the baseline score(s) established in (a).

14 . The method of claim 13 , wherein the behavioral test(s) performed in (a) and (c) comprise one or more of: Vineland Adaptive Behavior Scales-II (VABS-II), Vineland Adaptive Behavior Scales-III (VABS-III), Clinical Global Impression Scale (CGI), Pervasive Developmental Disorder Behavior Inventory (PDDBI), Expressive One-Word Picture Vocabulary Test-4 (EOWPVT-4), Aberrant Behavior Checklist, Sensory Experiences Questionnaire, Repetitive Behavior Scale, Intelligence Scales (Mullen Scales of Early Learning or Stanford-Binet), Language Environment Analysis, ATN GI Symptoms Inventory, and Parenting Stress Index.

15 . The method of claim 13 , wherein reevaluation of the patient in (c) is performed at one or more time points comprising: 2 months, 4 months, 6 months, 9 months, 12 months, 18 months, 24 months, 2 years, 3 years, 4 years, 5 years, 10 years, 15 years, 20 years or indefinitely post-administration.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2021
From: KURTZBERG, JOANNE; SUN, JESSICA; DAWSON, GERALDINE
To: DUKE UNIVERSITY
Reel/Frame 055908/0573 →
Continuity (2)
Provisional Application 62652722 · Apr 4, 2018
Related Publication 20210128631A1 · May 6, 2021
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